The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.
This is a multicenter, single-arm, open-label (all people involved know the identity of the intervention), single-dose study to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time), safety and tolerability of tapentadol 1 mg/kg oral solution (OS) in children aged from 6 to less than 18 years after scheduled surgical procedures that routinely produce acute, moderate to severe postsurgical pain. A screening phase, as per standard of care but not exceeding 30 days, will include the preoperative evaluation, the surgical procedure and its immediate post recovery, and will be followed by the open-label treatment phase and end-of-study assessments. Study drug administration will take place after the surgery has been completed, when the patient is alert, orientated, able to follow commands and complete the required postoperative procedures, and able to tolerate fluid and medication orally. Confinement to the study center for a patient will be as per standard of care, and will include the surgery, the entire 15-hour postdose evaluation period and the end-of-study evaluations. Children with a body weight less than 20 kg will be dosed with a single dose of tapentadol 4 mg/mL OS and children with a body weight of 20 kg or greater will be dosed with a single dose of tapentadol 20 mg/mL OS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Tapentadol OS Bodyweight \<20 kg: Type=4 unit=mg/mL form=oral solution route=oral use or Tapentadol OS Bodyweight \>=20 kg: Type=20 unit=mg/mL form=oral solution route=oral use. Single oral dose administered once.
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Little Rock, Arkansas, United States
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Washington D.C., District of Columbia, United States
Unnamed facility
Meridian, Idaho, United States
Pharmacokinetic profile
Time frame: 15 hours after the dose
number of patients with adverse events as a measure of safety and tolerability
Time frame: end of treatment (from 15 hours post treatment to discharge or early withdrawal)
Number of patients with adverse events as a measure of safety and tolerability
Time frame: Up to 15 hours post treatment on Day 1
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Unnamed facility
Ann Arbor, Michigan, United States
Unnamed facility
The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Toledo, Ohio, United States
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Pittsburgh, Pennsylvania, United States
Unnamed facility
Salt Lake City, Utah, United States
...and 7 more locations